Regeneron Pharmaceuticals, Inc. v Merus B.V
[2015] APO 50
•17 August 2015
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Regeneron Pharmaceuticals, Inc. v Merus B.V. [2015] APO 50
Patent Application: 2009263082
Title:Antibody producing non-human mammals
Patent Applicant: Merus B.V.
Opponent: Regeneron Pharmaceuticals, Inc.
Delegate: Keith Wagg
Decision Date: 17 August 2015
Hearing Date: Written Submissions
Catchwords: PATENTS – Extension of time to file evidence in answer – Reg. 5.9 – expert unexpectedly required to travel during the evidentiary period – action by the applicant was prompt and diligent and they made all reasonable efforts to meet the filing requirements – extension of time granted – costs awarded against opponent.
Representation: Patent applicant: Freehills Patent Attorneys
Opponent:Phillips Ormonde Fitzpatrick
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2009263082
Title:Antibody producing non-human mammals
Patent Applicant: Merus B.V.
Date of Decision: 17 August 2015
DECISION
The extension of time to file evidence in answer is granted for one month from 2 May 2015 to 2 June 2015. Costs are awarded against the opponent.
REASONS FOR DECISION
Background and Opposition
Patent application number 2009263082 (the patent), in the name of Merus B.V. (the applicant) was advertised as accepted on 20 March 2014. A notice of opposition to the grant of the patent was filed by Regeneron Pharmaceuticals, Inc. (the opponent) on 20 June 2014. Filing of the statement of grounds and particulars followed on 22 September 2014. Evidence in support was filed on 22 December 2014 and an extension of time sought to file more evidence. On 2 February 2014 the Commissioner formally advised that the extension of time to file evidence in support had been refused. This set the due date for evidence in answer to be 2 May 2015.
On 31 March 2015, the applicant filed an application for an extension of time (the application) of one month in which to file evidence in answer. A delegate of the Commissioner of Patents requested further information on the application on 2 April 2015. The applicant responded in a letter dated 9 April 2015 (the response). After the response was considered the Commissioner sent a notice of intention to allow the extension unless a hearing was requested.
On 28 April 2015 the opponent objected to the allowability of the extension and requested to be heard by way of written submissions.
Written submissions in chief were filed by both parties on 18 May 2015 and written submissions in reply were filed by each party on 25 May 2015.
The Law
On 15 April 2013, the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No 1) (the Amendment Regulation) commenced. The Amendment Regulation significantly amended the Patents Regulations (the Regulations) as they apply to patent oppositions. The law governing extensions of time to file evidence in a patent opposition depends upon the date on which the opposition commenced. Where the opposition commenced on or after 15 April 2013 (as in the present case), the extension is governed by regulation 5.9 of the Regulations as in force on 15 April 2013.
Subregulation 5.9(2) states:
The Commissioner may extend the period only if the Commissioner is satisfied that:
1. the party who intended to file evidence in the period:
(i)has made all reasonable efforts to comply with all relevant filing requirements under this Chapter; and
(ii)despite acting promptly and diligently at all times to ensure the appropriate evidence is filed within the period, is unable to do so, or
2. there are exceptional circumstances that warrant the extension.
Exceptional circumstances are defined in subregulation (5):
In this regulation:
exceptional circumstances includes the following:
(a) a circumstance beyond the control of a party that prevents the party from complying with a filing requirement under this Chapter;
(b) an error or omission by the Commissioner that prevents a party from complying with a filing requirement under this Chapter;
3. an order of a court, or a direction by the Commissioner, that the opposition be stayed pending the completion of a related proceeding or action under the Act.
As noted in the Explanatory Statement accompanying the Amendment Regulation:
"The Commissioner will not be able to extend time periods unless one of these conditions was made out. The party seeking the extension will bear the onus of convincing the Commissioner of this. Once the conditions in subregulation 5.9(2) are met, the Commissioner still has the discretion to consider whether or not it is appropriate that an extension of time be granted. In applying the test, the Commissioner will not be required to give a direction to extend a period solely because of delays caused by a legal representative failing to act promptly or diligently, by difficulties in obtaining expert evidence that could have been anticipated and acted on or by attempts to settle the proceedings.
Where a party cannot satisfy the Commissioner that an extension is justified under the test, the Commissioner will not have the power to give a short extension to allow the filing of evidence immediately available or to validate evidence filed out of time."
These provisions have been considered by the Commissioner in TRED Design Pty Ltd v Julie-Anne McCarthy and Bradley McCarthy [2013] APO 57 (the TRED decision) and Merial Limited v Novartis AG [2013] APO 65 (the Merial decision). The principles applied in those decisions, which I accept as correct, are that I must ask myself the following questions:
- Has the party (and their attorney or agent) made all reasonable efforts to comply with all relevant filing requirements?
- Was the failure to file the evidence in time despite the party (and their attorney or agent) acting promptly and diligently at all times to ensure the evidence is filed in time?
- Were there exceptional circumstances that warrant the extension?
I can extend the time for filing evidence only if I am satisfied that the answer to questions 1 and 2 is YES, or if I am satisfied that the answer to question 3 is YES. If I am so satisfied, then I must consider whether there are any discretionary reasons why the extension should not be granted.”
If the Commissioner is satisfied that an extension is appropriate, the Commissioner must then determine the length of the extension (subregulation (3).
The Commissioner must determine the length of the extended period having regard to what is reasonable in the circumstances.
The demonstration of prompt and diligent action was noted in TRED at [76]:
“An attorney does not need to account for every minute of their day, but they must provide enough information to enable a delegate of the Commissioner to form their own opinion on whether the party has acted reasonably, promptly and diligently. The kind of information that could be provided is a brief account of actions taken (for instance, an outline of what was done, when it was done, how it was done, by whom it was done, as appropriate to the case) covering the period in question.”
It was stated by the delegate in Fugro Airborne Surveys Corp v Geotech Airborne [2014] APO 23 (Fugro) at [20] that a chronology of the steps taken is usually a good starting point to assess whether a person has acted promptly and diligently:
“A party seeking an extension of time will assist the Commissioner (and advance their own cause) if they provide information about what they did, when they did it, and how long those actions took. When considering such information, it is relevant to consider whether there have been any significant unexplained delays. The presence of significant delays without a reasonable explanation is the antithesis of acting promptly and diligently.”
In Osmose New Zealand v Zelam Limited [2014] APO 49 (Osmose) the delegate noted at [18] and [22] that:
“The fact that some activities took place over several months does not automatically mean that Zelam have not been prompt and diligent.” … “While it might have been possible to carry out some activities faster, the time taken is not outside the range of prompt and diligent given the work that was involved.”
At the same time, it appears to be the case that an assessment of the reasonableness of a parties’ actions will equate with an assessment of whether they have been prompt and diligent. This was the case in Innovia Security Pty Ltd v Visual Physics LLC [2014] APO 15 where the Deputy Commissioner stated:
“…If I find that Innovia has been prompt and diligent in relation to the evidence in reply it will also have made all reasonable efforts…”
Chronology
It is useful to look at the chronology of events provided in the applicant’s submissions under “The Facts” starting at the bottom of page 2.
Date Opposition timeline Action by applicant 28 August 2014 A first expert for evidence in answer was contacted. 22 September 2014 Statement of Grounds and Particulars filed. 29 October 2014 A further expert for evidence in answer was contacted 22 December 2014 Extension of time to file evidence in support sought 24 December 2014 Evidence in Support filed
21 January 2015 Commissioner informs parties she intends to refuse extension of time 2 February 2015 Commissioner formally informs parties the extension of time to file evidence in support has been refused. Evidence in answer due 2 May. 4 February 2015 Experts confirmed their availability their availability throughout three month period 2 February 2014- 6 March 2015 Review of evidence in support 6 March 20145 Meeting held with Dutch attorneys and applicant to start preparation of evidence in answer 9 March 2015 Documents sent to experts 17, 18 and 20 March 2015 Meetings held with the two experts. 23 March and 30 March 2015 Additional meetings with both experts 31 March 2015 Applicant request extension of time to file evidence in answer First two weeks of April 2015 6 meetings held with experts including 4 with the expert heading overseas. 1 June 2015 Applicant files part of their evidence in answer. I will now look at the actions of the applicant in order to answer the following questions:
Has the applicant made all reasonable efforts to comply with all relevant filing requirements? Was the failure to file the evidence despite prompt and diligent action at all times?
In order to answer these questions it is necessary to understand the reasons why the applicant was unable to meet the filing requirements.
The reasons provided for the extension are at paragraph 24 of the applicant’s submissions in chief:
“The primary basis on which the Applicant requests further time to complete evidence in answer is the unexpected travel of one of the experts. A secondary basis is the complexity of both the subject matter of the claims and the bulk of the evidence in support filed”
Firstly, the primary reason is unforeseen travel. The applicant tells me in paragraph 27 of the submissions in chief that:
“…one expert advised that he was unexpectedly required to travel overseas from mid-April until the beginning of May 2015….this travel period was not foreshadowed when the expert was contacted on 4 February 2015 to confirm his availability. This travel was completely unexpected to the Applicant and its representatives.”
There was no attempt made to engage a different expert because (paragraph 11 of submissions in response):
“…it is plainly unreasonable to suggest that work of an expert who is available for 10 out of the 13 weeks to prepare evidence in answer be thrown out, and an entirely new expert identified and briefed leaving little over a month…prepare substantive evidence in answer.”
It was on 17 March 2015 when the experts advised of the travel. After becoming aware an extension of time was required, the application was filed on 31 March 2015. I note that this was slightly more than a month before the evidence in answer was due.
If the travel had been known about in advance, then looking for alternative experts would be considered to be prompt and diligent. However, because in this case the travel was not foreseen, I do not find the applicant’s actions less than prompt and diligent and I accept their primary reason for the extension.
The secondary reason provided is in regards to the subject matter and bulk of the material. I accept that the subject matter requires time, however, I note that the Statement of Grounds and Particulars itself is only 35 pages and the evidence in support is only two short declarations, one being 4 pages and the other being 6 pages. There are some annexes to the evidence as well, and these include 9 documents. The majority of the 1200 pages discussed are in documents cited in the statement of grounds and particulars which were not filed in evidence.
As the applicants point out, evidence in answer is by definition evidence in answer to the evidence in support.
Although the primary reason appears valid, I am still required to be satisfied that the applicant has acted promptly and diligently at all times.
The opponents have highlighted the lengths of time between actions and believe there are unexplained delays (from pages 5-8 of their submissions in chief).
It is useful to look at each of these separately.
Actions between receiving the Statement of Grounds and Particulars and being notified when evidence in answer is due
The opponents focused on this period in their submissions stating:
“The review of the 1200 pages of the Statement of Grounds and Particulars submitted on 22 September 2014 appears to have commenced 2 February, more than 19 weeks after it was received.”
They also state that:
“no action was taken in the period from 22 December to 2 February 2015 to review the filed evidence.”
The applicants did comment on this period in their submissions in chief stating that they corresponded with Dutch counsel and advised them regarding the extension of time. They also state that (in paragraph 5 of their responding submissions):
“…the experts are engaged to assist in preparing evidence in answer which is by definition answer to the evidence in support and not in answer to the Statement of Grounds and Particulars…prior to the Statement of Grounds and Particulars being filed, a first expert was identified contacted and retained, and then after the Statement of Grounds and Particulars was filed a further expert was identified, contacted and retained.”
Given this explanation I do not feel that waiting for evidence in support to be complete to start preparation of evidence in answer can be considered indicative of a party not acting promptly and diligently. It is not an unexplained delay in the evidentiary period.
However, it does appear that the applicant made the decision not to review the Statement of Grounds and Particulars and mentioned documents until the start of evidence in answer other than to find suitable experts. I have received no submissions on whether or not this decision was reasonable or if it would have been prompt and diligent to review this earlier. This strategy is easy to criticise in hindsight but given the nature of oppositions spending a lot of time upfront on this sort of thing may be pointless, and expensive, until the full case is established i.e. evidence in support has been filed. I therefore feel that although this could have been approached differently, it is not outside the range of prompt and diligent and is consistent with previous office decisions such as Shelford Services Pty Limited v Baylor Research Institute [2014] APO 20 at paragraph 18.
The opponents also thought it took too long for the first meeting to be held between the Australian and Dutch attorneys and then for the first meeting with the experts. They state that it was 10 weeks after evidence in support was filed (24 December 2014) for the attorneys to meet on 6 March and 12 weeks till they first met with the experts (17 March). However, during this time the outcome of the extension of time for further evidence in support was not known more evidence in support could have been coming in 3 month. This was on 2 February 2015 and given my acknowledgement of this above I will focus on the period from 2 February to 6 March.
The period from 2 February to the first meeting on 6 March
The applicant’s Australian attorneys and their Dutch attorneys reviewed the evidence in support after it was complete on 2 February and met on 6 March before starting work with the experts on evidence in answer on 17 March 2015.
While this review took a little over a month, they commented that the Statement of Grounds and Particulars, annexed documents and evidence in support is substantive and voluminous. The mentioned documents in the statement of grounds and particulars are however quite voluminous and when this is considered together with the evidence there is around 1200 pages.
In hindsight, review of the Statement of Grounds and Particulars and mentioned documents could have taken place earlier. However, the applicant did not know that the expert would be going overseas at when this could have taken place and instead decided to defer costs and wait until evidence in support was complete. This strategy is not outside the realms of prompt and diligent and is consistent with Shelford.
I note that some actions may take longer than others and that the applicant and their representation cannot be expected to drop everything else while one opposition is taking place. If other tasks came up which required immediate attention, this could explain a 6 week time frame to review it. Given this, I do not consider that taking a little over a month to review the substantive evidence is outside the realms of prompt and diligent action. I do not consider it to be an unexplained delay in these circumstances.
The opponents highlight the lack of detail (on page 8 of their submissions in chief) provided in the communications between the Applicant and the experts between 22 September and 9 March 2015. Given the facts above I will only look at between 4 February 2015 and 9 March 2015.
As discussed in Shelford at 22-25 it is considered reasonable for the applicant’s attorneys to review evidence in support on their own, formulate questions or issues that they can have the experts focus on, and address and therefore instructing their experts accordingly. This appears to be the strategy adopted here.
I do not believe providing specific detail regarding correspondence between an Attorney and their client is necessary to establish promptness and diligence in these circumstances. I have been told (in submissions) that the experts were retained during this period and it is clear that the attorneys (both the Australian and Dutch) were waiting to review the evidence in support for themselves before approaching the experts to prepare the evidence. Any further detail on the specific correspondence would not be of any benefit to either side of this case.
Delay in filing the application and inadequate explanation of actions
The opponents also state that there is an inadequate explanation of the actions taken (page 8 and 9 of the opponent’s submissions in chief). They specifically question why the application was not filed until two weeks after the first meeting with the expert. At this stage the attorneys had reviewed the documentation and well after they knew the complexity of it.
The opponents also mention that there is no indication of the actual time spent on the preparation of the evidence.
With regard to the above two points. I note that some evidence was filed on time and it only took two weeks before they realised they would need an extension. I also note that the extension was applied for a month before the deadline. This action leads directly to the inference that that the applicant did work promptly and diligently to ensure they met the filing requirements and it was only when it was clear the evidence could not be completed on time they filed the application for the extension.
Summary on reg 5.9
The primary reason for the extension was unexpected travel by one of the experts and not unexplained delays. The applicant acted promptly and diligently and managed to file some evidence on time. It was also prompt and diligent of the applicant to seek an extension as soon as it was clear that an extension was required. I am therefore satisfied that the applicant has acted promptly and diligently at all times and made all reasonable efforts to meet the filing requirements.
As I am satisfied under reg 5.9(2)(a), there is no need to consider exceptional circumstances under reg 5.9(2)(b).
The period of delay is consistent with the extension requested. Therefore I feel that one month is appropriate.
Discretionary considerations
The regulations set the criteria for which the Commissioner must be satisfied of in order for her to be able to exercise her discretion and grant and extension of time. As the criteria have been met I see no reason not to grant the extension of time.
Therefore I grant the extension of time for one month under reg 5.9(2)(a).
Conclusion
The opposition fails and the extension of time of one month from 2 May 2015 to 2 June 2015 is granted. Evidence in reply is due 2 months from the date of this decision.
Costs
It is usual that costs should follow the event and the applicant sought costs in their submissions in chief. The opposition has failed and the facts which lead to this decision were available in the application and the response. I therefore award costs against the opponent under Schedule 8.
Keith Wagg
Delegate of the Commissioner of Patents
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